Parsippany, New Jersey. Edenbridge Pharmaceuticals, LLC today announced that it has received approval from the U.S. Food and Drug Administration on its 505(b)(2) New Drug Application (NDA) for DARTISLA ODT (glycopyrrolate) orally disintegrating tablets. DARTISLA ODT is available in a 1.7 mg orally disintegrating tablet and is indicated for adults to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer. Edenbridge will launch this product to the market in early 2022 as its first branded specialty prescription product.
“We are thrilled to receive approval for DARTISLA ODT, which will provide physicians and patients with a novel treatment option,” remarked Daniel G. Worley Jr., Edenbridge’s Vice President of Business Development and Associate General Counsel. “This marks a major milestone for Edenbridge as our first 505(b)(2) NDA to receive approval from the FDA. We look forward to this new chapter for our company as we continue our strategic expansion into branded specialty prescription products.”
DARTISLA ODT is manufactured by Catalent (NYSE: CTLT) using their proprietary Zydis®* orally disintegrating tablet delivery technology to create a freeze-dried tablet that disperses almost instantly in the mouth without water.
Patients receiving the 2 mg dosage strength of another oral tablet dosage form of glycopyrrolate may be switched to the 1.7 mg dosage strength of DARTISLA ODT.
DARTISLA ODT is not recommended for patients initiating treatment or receiving maintenance treatment with a lower dosage strength of another oral glycopyrrolate product (e.g., tablet strength of 1 mg). Patients who are at risk for anticholinergic toxicity due to various underlying medical conditions or who have hypersensitivity to glycopyrrolate or the inactive ingredients should not take DARTISLA ODT. Adverse reactions include blurred vision, drowsiness, decreased sweating, flushing, vomiting, constipation, dry mouth, tachycardia, and urinary retention. Please visit www.Dartisla.com and consult the full prescribing information for additional important information.